title: Promestriene, a specific topic estrogen. Review of 40 years of vaginal atrophy treatment: is it safe even in cancer patients?
abstract: Urogenital symptoms resulting from estrogen deficiency are common problems that impair quality of life and sexuality. Potentially, one out of three postmenopausal women could benefit from a vaginal estrogen therapy, but the fear of systemic absorption limits its use. Promestriene used vaginally to relieve vaginal atrophy is a locally effective estrogen that has not shown systemic estrogenic effects. Thus, it could be a first-line option for those who necessitate a minimal or ideally no vaginal absorption, particularly in symptomatic cancer patients. There are little data available in the literature, mostly consisting of small, open-label, short duration studies, and few randomized-controlled studies. After a long-term market experience (almost 40 years), in 34 countries, and millions of pieces prescribed, the side effects were very rarely reported in pharmacovigilance data, whereas the effectiveness to relieve atrophy was good. To further improve promestriene safety, especially in estrogen-sensitive cancer patients, a very low dose is used from the beginning, starting from half or less of the usual dose, and then gradually increased till the minimum effective dose, which could further reduce its already minimal vaginal absorption.
authors.affiliation: Departments of aGynecological Oncology bMedical Oncology cScientific Direction, National Cancer Institute, Aviano (PN) dHematology-Oncology and Stem Cell transplantation Unit eDepartment of Uro-Gynecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori 'Fondazione Giovanni Pascale' - IRCCS, Naples, Italy.
authors.forename: Lino
authors.initials: L
authors.lastname: Del Pup
authors.forename: Raffaele
authors.initials: R
authors.lastname: Di Francia
authors.forename: Carla
authors.initials: C
authors.lastname: Cavaliere
authors.forename: Gaetano
authors.initials: G
authors.lastname: Facchini
authors.forename: Giorgio
authors.initials: G
authors.lastname: Giorda
authors.forename: Paolo
authors.initials: P
authors.lastname: De Paoli
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Berretta
mesh_terms: D000282:Administration, Intravaginal; D001284:Atrophy / Q000150:complications / Q000188:drug therapy / Q000473:pathology; D002986:Clinical Trials as Topic; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D009369:Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy; D016896:Treatment Outcome; D014621:Vagina / Q000378:metabolism / Q000473:pathology*
chemical_list: D004958:Estradiol; C013657:promestriene